NICE says initial 'no' to MS treatment daclizumab
Daclizumab, which is administered through a monthly injection, was licensed to treat people with relapsing forms of MS by the European Medicines Agency (EMA) in July 2016.
In its initial decision, NICE says issues with the clinical and cost effectiveness models presented by the pharmaceutical company Biogen represent a high degree of uncertainty.
NICE is now welcoming feedback on its initial decision from patient groups, health care professionals and others.
We’ll be submitting our views and encouraging NICE to reverse its negative decision. People with MS can also submit their own feedback through the appraisal consultation on the NICE website.
Biogen has also been asked to provide further evidence.
Safe and effective treatment
Daclizumab has been shown to be an effective and safe treatment. But without NICE approval, the treatment will be hard for people to get.
Emma Gray, our Interim Assistant Director of Research, said:
“It's disappointing to see daclizumab not recommended at this stage but we will be urging NICE to overturn its decision – we’ve seen this happen before with other MS treatments.
“There are more than 100,000 people living with MS in the UK. It’s an unpredictable and challenging condition to live with, but access to the right treatment and care can make a huge difference. As part of our Treat Me Right Campaign we’re calling for approved medicines, including daclizumab, to be made available on the NHS so that people have a wide range of choices."
Northern Ireland and Scotland
This decision also applies to England and Wales.
The Department of Health in Northern Ireland is expected to make a decision shortly. Its decisions are usually based on those made by NICE.
In Scotland, separate appraisals are carried out by the Scottish Medicines Consortium (SMC) and usually follow a NICE appraisal.
We want to hear from you if you’ve been involved in the trials for daclizumab to support our submission to NICE.
>> Email firstname.lastname@example.org to find out how you can get involved.